Severe Fecal Incontinence Research Articles

Assessing anorectal function in patients with recurrent ulcerative colitis

PurposeUlcerative colitis (UC) is an inflammatory bowel disease with an unclear etiology that can lead to irreversible changes in distal colonic function in chronic patients. This study investigated anorectal function in recurrent UC patients and identified influencing factors.MethodsThis prospective study enrolled 33 recurrent UC patients and 40 newly diagnosed patients from January 2019 to December 2022. Data collection included clinical records, scores, and anorectal function assessments. Regression analyses were used to identify factors impacting anorectal function.ResultsRecurrent UC patients had higher baseline CRP and fecal calprotectin levels, increased anxiety and depression, and more severe fecal incontinence. They also had lower BMIs, serum Hb and albumin (ALB) levels, and Inflammatory Bowel Disease Questionnaire scores than did initial-onset UC patients. Multivariate linear regression analysis revealed that long disease duration (coef. − 0.376, P < 0.001) and high fecal calprotectin level (coef. − 0.656, P < 0.001) independently influenced the initial sensation threshold in recurrent UC patients. Additionally, high fecal calprotectin (coef. − 0.073, P = 0.013) and high Zung Self-Rating Anxiety Scale score (coef. − 0.489, P = 0.001) were identified as two independent determinants of the defecation volume threshold. For the defecation urgency threshold, the independent factors included high disease duration (coef. − 0.358, P = 0.017) and high fecal calprotectin level (coef. − 0.499, P = 0.001). Similarly, the sole independent factor identified for the maximum capacity threshold was high fecal calprotectin (coef. − 0.691, P = 0.001).ConclusionRecurrent UC patients had increased rectal sensitivity and compromised anorectal function, which significantly impacted quality of life. Proactively managing the disease, reducing UC relapses, and addressing anxiety are effective measures for improving anorectal function in these patients.

Dietary Intake and Symptom Severity in Women with Fecal Incontinence

Introduction and HypothesisThe goal of this study was to determine whether dietary fat/fiber intake was associated with fecal incontinence (FI) severity.MethodsPlanned supplemental analysis of a randomized clinical trial evaluating the impact of 12-week treatment with percutaneous tibial nerve stimulation versus sham in reducing FI severity in women. All subjects completed a food screener questionnaire at baseline. FI severity was measured using the seven-item validated St. Mark’s (Vaizey) FI severity scale. Participants also completed a 7-day bowel diary capturing the number of FI-free days, FI events, and bowel movements per week. Spearman’s correlations were calculated between dietary, St. Mark’s score, and bowel diary measures.ResultsOne hundred and eighty-six women were included in this analysis. Mean calories from fats were 32% (interquartile range [IQR] 30–35%). Mean dietary fiber intake was 13.9 ± 4.3 g. The percentage of calories from fats was at the higher end of recommended values, whereas fiber intake was lower than recommended for adult women (recommended values: calories from fat 20–35% and 22–28 g of fiber/day). There was no correlation between St. Mark’s score and fat intake (r = 0.11, p = 0.14) or dietary fiber intake (r = −0.01, p = 0.90). There was a weak negative correlation between the number of FI-free days and total fat intake (r = −0.20, p = 0.008). Other correlations between dietary fat/fiber intake and bowel diary measures were negligible or nonsignificant.ConclusionOverall, in women with moderate to severe FI, there was no association between FI severity and dietary fat/fiber intake. Weak associations between FI frequency and fat intake may suggest a role for dietary assessment in the evaluation of women with FI.

Irritable bowel syndrome worsens faecal incontinence after primary repair of major obstetric anal sphincter injuries.

Obstetric anal sphincter injuries (OASIS) occur in approximately 3%-6% of vaginal deliveries and are the leading risk factor for late-onset faecal incontinence, which is an underdiagnosed pathology. The aim of this work was to use a validated scoring system to quantify the effect of irritable bowel syndrome (IBS) on the severity of faecal incontinence symptoms after primary repair of major OASIS (Grade IIIb-IV). A prospective cohort study was performed on all women who underwent primary repair of major OASIS over a 6-year period. They were assessed with ultrasonography within 12 weeks. Two control groups (who did not have OASIS) were women who underwent elective caesarean section and primigravid women. Questionnaires were sent at least 12 months after delivery, or at first consultation for primigravids, which generated the main outcome measures: Cleveland Clinic faecal incontinence severity scores and the presence of IBS based on Rome III criteria. There was a total of 211 patients included in the three groups and the mean follow-up time was 26 months after sphincter repair. Ultrasonographic sphincter defects were detected in 37% but did not affect the faecal incontinence score (p = 0.47), except in patients with IBS. Within each group, patients with IBS had significantly worse faecal incontinence than those without. Women with both OASIS and IBS had the most severe faecal incontinence scores. OASIS has a limited negative effect on faecal incontinence, independent of whether residual ultrasonographic sphincter defects are present. However, the presence of IBS has a significant compounding effect on faecal incontinence in OASIS patients. The effect of IBS on faecal incontinence is also notable in caesarean section patients and primigravids, suggesting that IBS is an independent risk-factor that should have its place in predelivery assessment and counselling.

Design of Novel Artificial Anal Sphincter

ObjectivesArtificial anal sphincter is considered to be a good method for the treatment of severe fecal incontinence, but there are problems of low biomechanical compatibility in clinical application. The purpose of this study is to design a novel artificial anal sphincter that can output stable loading force to solve the mechanical mismatch between artificial anal sphincter and intestinal tissue caused by excessive or too small local pressure on the intestine. Material and methodsAiming at the shortcomings of the existing artificial anal sphincter, a novel artificial anal sphincter with constant force mechanism is designed based on the C-shaped SMA sheet of Ti-55.9at%Ni and combined with the normal defecation mechanism of human body. In this paper, the chord length l of C-shaped SMA sheet is used as the design variable, and the artificial anal sphincter is optimized and verified initially by using finite element analysis method. ResultsThe results show that the artificial anal sphincter can achieve a constant force to clamp the intestine in a large displacement range when the chord length l of the C-shaped SMA is 13 mm, the chord height h is 1.5 mm, the width w is 2 mm, and the thickness δ is 0.2 mm. ConclusionThe design of artificial anal sphincter with constant force loading mechanism has a good effect in solving the biomechanical compatibility problem between the implant device and the intestinal tissue. In addition, the designed artificial anal sphincter occupies a small space, which provides a new idea for future clinical application.

Long-term cost-effectiveness analysis of sacral neuromodulation in the treatment of severe faecal incontinence.

The aim of this study was to evaluate the long-term cost-effectiveness of sacral neuromodulation in the treatment of severe faecal incontinence as compared with symptomatic management. In the public health field, a micro-costing evaluation method was conducted from the perspectives of the health system and the society. The incremental cost-effectiveness ratio was used as a decision index, and we considered various scenarios to evaluate the impact of the cost of symptomatic management and percutaneous nerve evaluation success rate in its calculation. Clinical data were retrieved from a consecutive cohort of 93 patients with severe faecal incontinence undergoing sacral neuromodulation after a failure of conservative (pharmacological and biofeedback) and/or surgical (sphincteroplasty) first-line treatments were considered. The long-term incremental cost-effectiveness ratio comparing sacral neuromodulation versus symptomatic management was 14347€/QALY and 28523€/QALY from the societal and health service provider's perspectives, respectively. If the definitive pulse generator implant success rate was 100%, incremental cost-effectiveness would correspond to 6831€/QALY and 16761€/QALY, respectively. Sacral neuromodulation may be considered a cost-effective technique in the long-term treatment of severe faecal incontinence from the societal and health care sector perspectives. Improving patient selection and determining the predictive outcome factors for successful sacral neuromodulation in the treatment of faecal incontinence would improve cost-effectiveness.

Young women and elderly men at risk of severe faecal incontinence: results of a French nationwide database analysis

The incidence of severe faecal incontinence (FI) in young people is likely underestimated. The objective of this study is to assess the incidence of FI by using the French national insurance information system (SNDS). The SNDS was used, including 2 health insurance claims databases. The study included 49,097,454 French people who were ≥ 20years old in 2019. The main outcome measure was the occurrence of FI. In 2019, 123,630 patients out of the entire French population (n = 49097454) (0.25%) were treated for FI. The numbers of male and female patients were similar. The data showed a dramatic increase in the incidence of FI between the ages of 20 and 59 in female patients, compared to 60 and 79 in male patients.The risk of FI increased with age (OR of 3.6 to 11.3 depending on age). Women had a higher risk of severe FI compared to men between the ages of 20 and 39 (OR = 1.3; 95%CI:1.3-1.4) and the ages of 40 and 59 (OR = 1.1; 95%CI:1.08-1.13). This risk decreased after the age of 80 (OR = 0.96; 95%CI:0.93-0.99).The rate of diagnosis of FI also increased where there were greater numbers of proctologists practising in the region of residence in question (OR of 1.07 to 1.35 depending on the number of proctologists). Young women who have given birth and elderly men are at risk of FI and must be targeted by public health information campaigns. The development of coloproctology networks should be encouraged.

Sacral Neuromodulation Therapy for Urinary and Fecal Incontinence in Patients With Multiple Sclerosis: Report of 6 Cases and Literature Review.

Urinary incontinence (UI) and fecal incontinence (FI) are challenging manifestations of multiple sclerosis (MS) that have historically been treated with limited success. Sacral neuromodulation (SNM) has provided successful resolution of UI and FI in the general population and in patients with neurologic conditions, including MS. We report on 6 patients with MS-related incontinence treated successfully with SNM and review the literature. Medical records were reviewed retrospectively to identify patients with MS seeking treatment for incontinence. Six patients were identified, and each is presented with follow-up assessment of the severity of UI or FI. All 6 individuals with MS had severe incontinence that had been refractory to therapies that included medications and pelvic floor physical therapy. Five patients reported severe UI and 2 patients reported severe FI. Each patient was successfully treated with SNM, with large reductions of incontinence scores and improved quality of life. In this case series, SNM was effective as a treatment for UI and FI among patients with MS. These findings confirm other published series that have reported the success of SNM in patients with MS with incontinence. Sacral neuromodulation should be considered as a potential treatment option for patients with MS and UI and/or FI.

Gastric Outlet Obstruction Secondary to Incarcerated Stomach in Parastomal Hernia

Gastric outlet obstruction due to an incarcerated stomach in a parastomal hernia is extremely rare. Here, we present the management of such a case with a review of the literature. A 79-year-old woman presented with a 3-week history of postprandial vomiting and associated parastomal and epigastric pain. She had a loop colostomy created for severe fecal incontinence secondary to anal stenosis. Imaging revealed a large parastomal hernia with an incarcerated gastric antrum. She was initially managed nonoperatively with a nasogastric tube. She underwent a semi-elective open Sugarbaker mesh repair of the parastomal hernia with good results. Gastric outlet obstruction secondary to incarceration of the stomach in a parastomal hernia is uncommon. A conservative approach with nasogastric tube decompression is a reasonable initial approach in a patient who is not critically unwell, which allows time for consideration of different parastomal hernia repair techniques.

Ventral Pelvio-anal Reconstruction as a Variation of Established Surgical Management of Severe and Refractory Fecal Incontinence: A Case Series Study

Background: Conventional treatments may not be effective in some severe cases of fecal incontinence (FI). Objectives: In the present study, we evaluated the applicability of ventral pelvio-anal reconstruction (VPAR) as a modified operative technique for 17 patients with severe and refractory FI. Methods: We performed VPAR by placing a mesh in the perineum and securing it at the sacrospinal ligament on both sides. The Cleveland Clinic Incontinence Score (CCIS) and Fecal Incontinence Quality of Life (FIQoL) questionnaires were completed by the patients, and anorectal manometry was performed before and after the operation (3,6 and 12 months), and the results were compared against the baseline values. Results: The operation was successful in all patients; no mesh was explanted during the follow-up period, and all patients reported satisfactory outcomes. Postsurgical anorectal manometry showed an increase in both rest and squeeze pressures. The CCIS decreased while the FIQoL increased significantly during the first-year follow-up (P &lt; 0.001). Conclusions: By incorporating the implant into the perineal body, we hypothesized that our combined technique would lead to favorable outcomes, and the preliminary results confirmed this. Further studies with larger patient populations and more extended follow-up periods are needed to confirm our satisfactory results and conclude that the VPAR approach is a safe and appropriate therapeutic option for patients with severe and refractory FI.

Economic burden of long-term treatment of severe fecal incontinence

IntroductionFind out the long-term economic cost associated with the treatment of severe fecal incontinence by SNS versus symptomatic conservative treatment and definitive colostomy. MethodsDetailed descriptive study of the costs of the healthcare process (interventions, consultations, devices, complementary tests, hospitalization, etc.) of 3 treatment alternatives for fecal incontinence using analytical accounting tools of the Health Service based on clinical activity data. The frequency of use of health resources or the quantity of products dispensed in pharmacies (medication, diapers, ostomy material, etc.) was estimated in each case. Costs derived from adverse situations were included. Patients with severe fecal incontinence, defined by a score greater than 9 on the Wexner severity scale, in whom first-line treatments had failed, were included.Data from a consecutive cohort of 93 patients who underwent an SNS between 2002 and 2016 were used; patients who underwent definitive colostomy (n=2); parastomal hernia (n=3); and colostomy stenosis (n=1). ResultsThe mean cumulative cost in 10 years per patient in each alternative was: € 10,972.9 symptomatic treatment (62% diapers); € 17,351.57 SNS (95.83% interventions; 81.6% devices); € 25,858.54 definitive colostomy (70.4% ostomy material and accessories). ConclusionsManagement of severe fecal incontinence implies a great burden in economic terms. The colostomy is the alternative that generates the most direct cost, followed by SNS and symptomatic treatment.

Mesh erosion into the rectum after laparoscopic posterior rectopexy: A case report

IntroductionRectal prolapse typically presents in elderly women with protruding full-thickness rectum from the anus. Rectopexy using mesh is known to be a highly curative treatment for rectal prolapse, however, this procedure carries the risk of severe complication as mesh erosion.Presentation of caseA 78-year-old woman who had undergone laparoscopic posterior rectopexy 4 years earlier visited the outpatient clinic with a complaint of bloody stool. A colonoscopy and computed tomography revealed that part of the mesh had migrated into the rectal lumen at 8 cm from the anal verge. Based on the above findings, a diagnosis of mesh erosion into the rectum was made. Complete removal of the mesh and tacker with rectal resection was performed. Before rectopexy, the patient had severe fecal incontinence, and her anal sphincter function was decreased, therefore, Permanent colostomy was indicated instead of anastomosis. In the resected specimen, the mesh was folded and placed in the mesenteric fat of the posterior wall of the rectum, with the corner of the edge of the mesh protruding into the inside lumen.DiscussionMesh erosion typically occurs when using mesh made of synthetic mesh and non-absorbable threads; it might induce chronic irritation and friction due to mesh shrinkage.ConclusionTo prevent mesh erosion, it is important to pay attention to the mesh materials used and ensure secure fixation.

Anorectal dysfunction in adults with spina bifida and associated socio-emotional factors-a retrospective, cross-sectional cohort study.

Retrospective, cross-sectional study. To investigate prevalence, types, and severity of fecal incontinence (FI) and constipation in adults with spina bifida (SB), in relation to self-perception and help-seeking, and to compare findings to data from a general population reference group. University Medical Center Groningen (UMCG), the Netherlands. The 294 adults with SB registered at UMCG in 2017 were invited to participate. The Groningen Defecation and Fecal Continence Questionnaire was used to assess functional outcomes for FI and constipation using Rome IV criteria. Vaizey (for FI) and Agachan (for constipation) scores were determined. Socio-demographic factors and self-perception of bowel-related problems were recorded through the questionnaire. Data were compared with an age and sex matched reference group. The completed questionnaires of 112 (38%) responding participants were analyzed. FI and constipation were more prevalent in the study group (35% and 45%, respectively) than in the reference group (8.9% and 22%, respectively). In general, in participants with SB aperta (SBA; n = 75), FI was more severe than in participants with SB occulta (SBO; n = 37). However, severity of FI was higher in SBO participants than in the SBA group after the age of 61. Bowel problems in adults with SB were associated with worse self-perception regarding health. In adults with SB, anorectal dysfunction is often present and severe. Older persons with SBO experience more severe FI than in early age. Bowel problems should systematically and more adequately be addressed and controlled throughout adulthood in both the spina bifida groups.

Sphinkeeper Procedure for Treating Severe Faecal Incontinence-A Prospective Cohort Study.

(1) Background: The Sphinkeeper implantation for faecal incontinence (FI) is a novel surgical procedure with limited data on its clinical efficacy. Therefore, we aimed to assess the functional outcome following Sphinkeeper surgery in patients with refractory FI. (2) Methods: Between 2018 and 2020, eleven consecutive patients (9 female) with FI met the inclusion criteria and were enrolled for surgery. Functional outcome and quality of life were evaluated by standard questionnaires pre- and post-surgery. Migration of protheses was demonstrated by 3D endoanal ultrasound. The median follow-up time was eight months (range 3–18 months). (3) Results: The median age was 75 years (range 46–89 years) with a median BMI of 27.4 (range 21.2–30.1). The median number of implanted prostheses per intervention was nine (range 9–10). We found no intraoperative or early postoperative complications. After two months, two prostheses in one patient had to be removed due to pain at the perianal skin site. The median St. Mark’s incontinence score decreased significantly from 22 to 13 points (p = 0.008). The SF-12 showed a significant improvement (35.9 versus 46.3) after surgery (p = 0.028). A migration of at least one prosthesis was observed in ten patients (91%). Six (60%) prostheses were found at the same level in another ten patients. (4) Conclusion: Sphinkeeper implantation is a promising surgical technique for patients with severe FI. The complication rate is low, and short-term functional improvement can be achieved even in severe forms of FI. Migration of implants commonly occurs.

Risk of Fecal Incontinence Following Receptive Anal Intercourse: Survey of 21,762 Men Who Have Sex With Men

BackgroundThe prevalence of receptive anal intercourse (RAI) is increasing. A few studies, with heterogeneous designs, have investigated the associated risk of fecal incontinence (FI). AimThe primary objective of this study was to determine FI prevalence in a population of men who have sex with men (MSM) engaging in RAI. The secondary objective was to identify risk factors for severe FI. Methods OutcomesAn online survey of 24,308 MSM was performed in 2019. Demographic and socioeconomic data were collected, together with information about RAI sexual practices, and FI defined by: “During the last month, have you experienced any involuntary leakage of stools?” Results Clinical ImplicationsIn total, 1,734 (8%) of the 21,762 participants reported FI. Mean age was 35.3 years. The prevalence of FI was correlated with RAI frequency: 12.7% (if RAI ≥ 1 /wk) versus 5.7% (if no RAI). In multivariate analysis, the factors associated with FI were age (OR: 1.01), low socioeconomic status (OR 1.32 to 1.40), HIV-seropositivity (OR: 1.78), high RAI frequency (OR: 1.64), chemsex (OR: 1.67) and fist-fucking (OR: 1.61). Strengths and LimitationsMain strengths of our study are population size and assessment of detailed modalities of sexual practices. Main limitations are the use of a convenience non-random sample and the assessment of FI only during the past month. ConclusionThis study of a large MSM population, highlights risk factors for FI among RAI practices: RAI ≥ 1 /wk, chemsex, fist-fucking, low socioeconomic status.Garros A, Bourrely M, Sagaon-Teyssier L, et al. Risk of Fecal Incontinence Following Receptive Anal Intercourse: Survey of 21,762 Men Who Have Sex With Men. J Sex Med 2021;18:1880–1890.

Comparative effectiveness of biofeedback and injectable bulking agents for treatment of fecal incontinence: Design and methods

Fecal incontinence (FI), the involuntary passage of stool, is common and can markedly impair the quality of life. Among patients who fail initial options (pads or protective devices, bowel modifying agents, and pelvic floor exercises), the options are pelvic floor biofeedback (BIO), perianal injection with bulking agents (INJ), and sacral nerve electrical stimulation (SNS), which have not been subjected to head-to-head comparisons. This study will compare the safety and efficacy of BIO and INJ for managing FI. The impact of these approaches on quality-of-life and psychological distress, cost effectiveness, and predictors of response to therapy will also be evaluated. Six centers in the United States will enroll approximately 285 patients with moderate to severe FI. Patients who have 4 or more FI episodes over 2 weeks proceed to a 4-week trial of enhanced medical management (EMM) (ie, education, bowel management, and pelvic floor exercises). Thereafter, 194 non-responders as defined by a less than 75% reduction in the frequency of FI will be randomized to BIO or INJ. Three months later, the efficacy, safety, and cost of therapy will be assessed; non-responders will be invited to choose to add the other treatment or SNS for the remainder of the study. Early EMM responders will be re-evaluated 3 months later and non-responders randomized to BIO or INJ. Standardized, and where appropriate validated approaches will be used for study procedures, which will be performed by trained personnel. Prospectively collected data on care costs and resource utilization will be used for cost effectiveness analyses.

Impacto económico del tratamiento a largo plazo de la incontinencia fecal grave

IntroductionFind out the long-term economic cost associated with the treatment of severe fecal incontinence by SNS versus symptomatic conservative treatment and definitive colostomy. MethodsDetailed descriptive study of the costs of the healthcare process (interventions, consultations, devices, complementary tests, hospitalization, etc.) of 3 treatment alternatives for fecal incontinence using analytical accounting tools of the Health Service based on clinical activity data. The frequency of use of health resources or the quantity of products dispensed in pharmacies (medication, diapers, ostomy material, etc.) was estimated in each case. Costs derived from adverse situations were included. Patients with severe fecal incontinence, defined by a score greater than 9 on the Wexner severity scale, in whom first-line treatments had failed, were included.Data from a consecutive cohort of 93 patients who underwent an SNS between 2002 and 2016 were used; patients who underwent definitive colostomy (n=2); parastomal hernia (n=3), and colostomy stenosis (n=1). ResultsThe mean cumulative cost in 10 years per patient in each alternative was: € 10,972.9 symptomatic treatment (62% diapers); € 17,351.57 SNS (95.83% interventions; 81.6% devices); € 25,858.54 definitive colostomy (70.4% ostomy material and accessories). ConclusionsManagement of severe fecal incontinence implies a great burden in economic terms. The colostomy is the alternative that generates the most direct cost, followed by SNS and symptomatic treatment.

Underwater endoscopic mucosal resection of a rectal adenoma in the nondistensible rectum from severe fecal incontinence

In a patient with severe fecal incontinence, polypectomy of rectal adenomas may be difficult if the patient cannot retain gas in the rectum. Existing literature does not include reports of the optimal polypectomy technique in these patients. We describe a challenging case of difficult polypectomy in the nondistensible rectum from severe fecal incontinence (Video 1, available online at www.giejournal.org).

Sacral nerve stimulation versus the magnetic sphincter augmentation device for adult faecal incontinence: the SaFaRI RCT.

Preliminary studies using the FENIX™ (Torax Medical, Minneapolis, MN, USA) magnetic sphincter augmentation device suggest that it is safe to use for the treatment of adult faecal incontinence, but efficacy data are limited. To compare FENIX with sacral nerve stimulation for the treatment of adult faecal incontinence in terms of safety, efficacy, quality of life and cost-effectiveness. Multicentre, parallel-group, unblinded, randomised trial comparing FENIX with sacral nerve stimulation in participants suffering moderate to severe faecal incontinence. Participants were randomised on an equal basis to either sacral nerve stimulation or FENIX. Follow-up occurred 2 weeks postoperatively and at 6, 12 and 18 months post randomisation. The primary outcome was success, defined as device in use and ≥ 50% improvement in Cleveland Clinic Incontinence Score at 18 months post randomisation. Secondary outcomes included complication rates, quality of life and cost-effectiveness. Between 30 October 2014 and 23 March 2017, 99 participants were randomised across 18 NHS sites (50 participants to FENIX vs. 49 participants to sacral nerve stimulation). The median time from randomisation to FENIX implantation was 57.0 days (range 4.0-416.0 days), and the median time from randomisation to permanent sacral nerve stimulation was 371.0 days (range 86.0-918.0 days). A total of 45 out of 50 participants underwent FENIX implantation and 29 out of 49 participants continued to permanent sacral nerve stimulation. The following results are reported, excluding participants for whom the corresponding outcome was not evaluable. Overall, there was success for 10 out of 80 (12.5%) participants, with no statistically significant difference between the two groups [FENIX 6/41 (14.6%) participants vs. sacral nerve stimulation 4/39 (10.3%) participants]. At least one postoperative complication was experienced by 33 out of 45 (73.3%) participants in the FENIX group and 9 out of 40 (22.5%) participants in the sacral nerve stimulation group. A total of 15 out of 50 (30%) participants in the FENIX group ultimately had to have their device explanted. Slightly higher costs and quality-adjusted life-years (incremental = £305.50 and 0.005, respectively) were observed in the FENIX group than in the sacral nerve stimulation group. This was reversed over the lifetime horizon (incremental = -£1306 and -0.23 for costs and quality-adjusted life-years, respectively), when sacral nerve stimulation was the optimal option (net monetary benefit = -£3283), with only a 45% chance of FENIX being cost-effective. The SaFaRI study was terminated in 2017, having recruited 99 participants of the target sample size of 350 participants. The study is, therefore, substantially underpowered to detect differences between the treatment groups, with significant uncertainty in the cost-effectiveness analysis. The SaFaRI study revealed inefficiencies in the treatment pathways for faecal incontinence, particularly for sacral nerve stimulation. The success of both FENIX and sacral nerve stimulation was much lower than previously reported, with high postoperative morbidity in the FENIX group. Further research is needed to clarify the treatment pathways for sacral nerve stimulation and to determine its true clinical and cost-effectiveness. Current Controlled Trials ISRCTN16077538. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 18. See the NIHR Journals Library website for further project information.

Sacral neuromodulation for the prevention of a permanent stoma in patients with severe defecation disorder following intersphincteric resection

Severe defecation disorder occurs frequently in coloanal anastomosis for low rectal cancer, and may affect quality of life. Sacral neuromodulation (SNM) has been reported to be successful after rectal resection, but there are no results for patients treated with intersphincteric resection (ISR). A retrospective single-center study of SNM was performed for patient with defecation disorder following ISR. Pre- and post-treatment bowel frequencies, fecal incontinence episodes, and Wexner, LARS and FIQL scores were assessed to evaluate the efficacy. A good response was defined as ≥ 50% reduction of bowel frequency per day or fecal incontinence episodes per week. 10 patients (7 males, mean age 67.5years) underwent SNM. All patients had severe fecal incontinence with a median Wexner score of 15 (13-20) and a median LARS score of 41 (36-41). The Wexner score improved after SNM, but not significantly (p = 0.06). LARS and FIQL scores significantly improved after SNM (p = 0.02, p = 0.01). At the end of follow-up, the good response rate was 40%. Three cases without a good response required creation of a permanent stoma. Seven out of 10 patients did not require a permanent colostomy after SNM. SNM should be considered before performing a permanent colostomy.

Long-term results of dynamic graciloplasty for severe fecal incontinence

Fecal incontinence is a common complaint. In the presence of extensive sphincter deterioration, after anorectal trauma, or failure of non-invasive surgical procedures, a sphincter reconstruction with dynamic graciloplasty can be proposed. The aim of our study was to evaluate the long-term results of dynamic graciloplasty. A retrospective study was conducted on all the patients who underwent dynamic graciloplasty between 1997 and 2019 in one French tertiary referral center for severe fecal incontinence after previous unsuccessful treatments. Only patients with available long-term results (≥ 1year) were included. Among 40 patients who underwent dynamic graciloplasty, 31 patients [77% women, median age = 57years (range 17-74years)] were included with a meanlong-term follow-up of 11 ± 6years. The mean duration of fecal incontinence was 8 ± 7.9years and the mean Wexner score was 16 ± 3. Fecal incontinence was adult-acquired in 88% of patients. 74% of patients underwent previously unsuccessful surgical procedures. A diverting colostomy was present in 7 patients (23%). Postoperative overall, surgical and major morbidity occurred in 20 (64%), 17 (55%) and 7 (23%) patients, respectively. At the end of follow-up, 18 patients still used their stimulation device (58%), and 4 patients required a permanent colostomy (12.5%). Long-term efficacy of dynamic graciloplasty was reported by 17 patients (55%). The efficacy of dynamic graciloplasty is conserved in 55% of patients after a mean follow-up of 11years. This procedure needs to be kept in the surgical armamentarium for persistent and severe fecal incontinence after previous surgical interventions or in the presence of large perineal defects, before the ultimate step of permanent stoma.